NCT00237263已完成2 期
An Extension Study to Phase IIb Dose-finding Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 285
- 试验地点
- 2
- 主要终点
- Incidence of adverse events during the long term treatment (maximum 3 years)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.
This study is not recruiting patients in the United States.
详细描述
The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Attended the Phase IIb study
- •Able to fill out the patient diary
排除标准
- •Serious heart, pulmonary, renal, hepatic or gastrointestinal disease
- •Dementia symptoms
- •Pregnant or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Incidence of adverse events during the long term treatment (maximum 3 years)
ECG at every 16 weeks
Blood pressure at every 12 weeks
Laboratory test at every 16 weeks
次要结局
- UPDRS score at every 16 weeks
- On time based on patient diary (up to 104 weeks)
研究者
研究点 (2)
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